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New registry to monitor penile implant success in 450 men

NCT ID NCT04200937

Disease control Sponsor: Boston Scientific Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 6 times

Summary

This study is a registry that collects real-world information on the safety and effectiveness of Boston Scientific penile implants for erectile dysfunction. It will enroll 450 men who are already scheduled to receive the implant. Researchers will track changes in erectile function, mood, and overall sexual satisfaction for years after surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 450 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2021

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult males who meet the indications for surgical correction of erectile dysfunction will be enrolled.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. ≥ 18 years of age. 2. Males who are determined to be suitable candidates and scheduled to undergo surgical implantation of a market approved BSC penile prothesis by their physician. 3. Willing and able to complete the informed consent process. 4. Willing and able to comply with the follow-up requirements. Exclusion Criteria: 1. Males who are deemed by their physician as not suitable candidates for a penile prosthesis. 2. In the opinion of the investigator, it is not in best interest of the patient or the study for the patient to participate.

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Conditions

The condition(s) this trial relates to.

erectile dysfunction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Erectile dysfunction

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    25 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Duke University Medical Center

    Raleigh, North Carolina, 27609, United States

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Indiana University Medical Center

    Indianapolis, Indiana, 46202, United States

  • Johns Hopkins Aramco Healthcare

    Dhahran, 34465, Saudi Arabia

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Ohio State University Wexner Medical Center

    Columbus, Ohio, 43212, United States

  • Peking University First Hospital

    Beijing, 100034, China

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095, United States

  • SIU School of Medicine

    Springfield, Illinois, 62702, United States

  • Shanghai General Hospital

    Shanghai, 200080, China

  • Shanghai Jiaotong University School of Medicine Renji Hospital

    Shanghai, 200127, China

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107, United States

  • Tower Urology-Research Facility

    Los Angeles, California, 99048, United States

  • USC Medical Center

    Los Angeles, California, 90033, United States

  • USF Health South Tampa Center for Advanced Healthcare

    Tampa, Florida, 33606, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Miami Hospital

    Miami, Florida, 33136, United States

  • University of Utah

    Salt Lake City, Utah, 84132, United States

  • University of Washington Medical Center

    Seattle, Washington, 98195, United States

  • W.G. Hefner VA Medical Center

    Salisbury, North Carolina, 28144, United States

  • Wake Forest University

    Winston-Salem, North Carolina, 27103, United States

  • Washington University in St. Louis

    St Louis, Missouri, 63110, United States

  • Willis-Knighton Medical Center

    Bossier City, Louisiana, 71111, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.